The U.S. Food and Drug Administration (FDA) inspected your firm located at 231 East Grand Blvd., Detroit, MI on October 22, 27, and 28, 2014 and November 10, 2014. During the inspection you provided the investigators with labels for six of your finished juice products. The inspection revealed that the juice products you manufacture are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. During our inspection of your juice processing facility we found serious violations of the Juice HACCP regulation, Title 21, Code of Federal Regulations (CFR), Part 120, and the Current Good Manufacturing Practice regulation for foods, Title 21, CFR Part 110.

During our inspection ending on November 10, 2014 we found you have serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation – Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with the requirements of 21 CFR Part 120, renders the juice products adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C §342(a)(4)]. Therefore, your ginger juice products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

1. You must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a). However, your firm does not have a HACCP plan for your 100% ginger root juice and 100% carrot juice ingredients to control the food safety hazards of pathogens.

Furthermore, your firm does not have a written Hazard Analysis to determine whether there are food hazards that are reasonably likely to occur, and to identify control measures that you can apply to control those hazards as required in 21 CFR 120.7(a), for the 100% ginger root juice and 100% carrot juice ingredients you manufacture for use in your beverages. A “food hazard” is defined in 21 CFR 120.3(g) as “any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.”

2. You must have a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing to comply with 21 CFR 120.6(a). However, your firm has no SSOP for the 100% ginger root juice and 100% carrot juice ingredients you manufacture for use in your beverages.

3. You must apply a process directly to your juice that will consistently produce a 5-log reduction of the pertinent microorganism for the shelf life of the product when stored under normal or moderate abuse conditions to comply with 21 CFR 120.24(a). However, you manufacture 100% ginger root juice and 100% carrot juice to be used as juice ingredients without applying a 5-log reduction treatment to either the juice ingredient or the finished product in your facility.

Current Good Manufacturing Practices

1.You failed to hold raw materials and ingredients at temperatures in a manner that prevents food from becoming adulterated, as required by 21 CFR 110.80(a)(5). On October 22, 2014 the investigator determined that your 100% carrot juice and 100% ginger root juice were stored in a refrigerator at a temperature of (b)(4) degrees.

2.You failed to maintain equipment, containers, and utensils used to store raw materials, work-in-process, or food in a manner that protects against contamination during manufacturing or storage, as required by 21 CFR 110.80(b)(7).

a.The investigator observed bottles and caps being stored in open containers that were in direct contact with the floor. These bottles and caps are used to package the finished juice product.

b.The refrigerator used to store raw materials was soiled with spilled juice residue.

3.You failed to handle work-in-process in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). For example, the mixing and assembly of Nikki’s Ginger Delight was conducted in (b)(4) gallon mixing pots that were placed directly on the floor throughout the mixing and filling process.

We received your letter dated December 18, 2014. Your letter responded to the Form FDA 483, Inspectional Observations, issued to your firm. We reviewed your response and conclude that it is not adequate to correct the violations.

Misbranding

Based on our review of your product labels collected during the inspection, we have determined that your ginger juice products are also misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Regulations implementing the food labeling requirements of the Act are found in Title 21, Code of Federal Regulations, Part 101.

1.Your Nikki’s Ginger Organic Carrot Apple, Nikki’s Ginger Organic Mint, and Nikki’s Ginger Organic Apple juice products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each product is fabricated from two or more ingredients and each ingredient is not declared on the label by its common or usual name and they purport to be beverages containing vegetable or fruit juice but fail to bear a percentage, as required by 21 CFR 101.4 and 101.30 (respectively). For example:

a.The products purport to be beverages containing fruit juice and/or vegetable juice, but the labels fail to bear a percentage declared by the words "Contains_ percent (or %)_ juice" or a similar phrase with the first blank filled in with the percentage of the juice and the second blank (if used) filled in with the name of the particular fruit or vegetable (e.g., "Contains 50 percent apple juice" or "50 percent juice") juice, as required by 21 CFR 101.30(b)(1).

b.The product labels fail to declare the common or usual name of the ingredients “water,” “agave syrup,” and “spices” in accordance with 21 CFR 101.4. The product labels declare “filtered water,” “agave nectar,” and “natural spices,” which are not the appropriate common or usual names.

2.Your Nikki’s Ginger Organic Carrot Apple, Nikki’s Ginger Organic Mint, and Nikki’s Ginger Organic Apple juice products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. For example, the product labels fail to declare a serving size that is determined from the “reference amount customarily consumed” (RACC) that is appropriate to the food as defined within 21 CFR 101.12. The serving size must be based on the 240mL RACC, and the label statement provided for beverages is 8 fl oz. (240mL). However, the labeled serving sizes for Nikki’s Ginger Organic Carrot Apple, Nikki’s Ginger Organic Mint, and Nikki’s Ginger Organic Apple tea products are currently provided in grams and ounces, which is not acceptable.

3.Your Nikki’s Ginger Organic Carrot Apple, Nikki’s Ginger Organic Mint, and Nikki’s Ginger Organic Apple juice products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

4.Your Nikki’s Ginger Organic Carrot Apple, Nikki’s Ginger Organic Mint, and Nikki’s Ginger Organic Apple juice products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the products bear or contain artificial coloring or chemical preservative but do not bear labeling stating that fact. Specifically, your products contain a chemical preservative, ascorbic acid, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). Ascorbic acid may be used as a chemical preservative (21 CFR 182.3013) or as a nutrient (21 CFR 182.8013). When used as a nutrient, it is a source of vitamin C. According to the nutrition labels, vitamin C is declared as 0% daily value (DV) on the Nikki’s Ginger Mint and Nikki’s Ginger Apple labels and 2% DV on the Nikki’s Ginger Carrot Apple label. Since the amount of ascorbic acid that is being used does not provide a significant amount of vitamin C, it does not qualify as a nutrient fortification.

We may take further action if you do not promptly correct these violations. Actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.

Please respond in writing within (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation such as copies of your juice HACCP Hazard Analysis, juice HACCP plans, process controls for 5-log reduction of pertinent microorganisms, sanitation monitoring records, revised product label(s), or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, provide a reason for your delay and state when you will correct any remaining deviations.

We offer the following additional comments about your labeling:

1. Your statement of identity includes “tea;” however, your products are beverages that are made from fruit and vegetable juices and do not contain any actual tea. The statement of identity must be an appropriately descriptive term that describes the basic nature of the food and its characterizing ingredients in accordance with 21 CFR 101.3(b) and 102.5.

2. A website or email address is not an acceptable substitute for the actual name and address of the place of business of the manufacturer, packer, or distributor.

3. The net quantity of contents declarations for the 32 oz. products also declares “473ML,” which is not mathematically consistent. It is also the same milliliter declaration that is declared on the 16 oz products. Additionally, the gram and ounce information provided is not mathematically consistent.

4. The nutrition information may only be provided inthe linear format if the product has a total surface area to bear labeling of less than 12 square inches,or if the product has a total surface area to bear labeling of 40 or less square inches and the package shape or size cannot accommodate a standard vertical column or tabular display. Although your response did not include actual bottles or photos of the bottles with the new labels,we were provided with photosof bottles with the old labels. We note the firm's old labelspresented the nutrition information in a standard vertical column; therefore,unless the shape of bottleshas been drastically changed,the photos of the bottles with old labels clearly show that the 16 fl.oz. and 32 fl.oz.bottles have sufficient surface area to accommodate labels with the standard vertical column display.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Send your response in writing to the U.S. Food and Drug Administration, Attention: Cicely Vaughn, Compliance Officer at 300 River Place, Suite 5900 Detroit, MI 48207-4291. If you have questions regarding any issues in this letter, please contact Cicely Vaughn at (313) 393-8297 or cicely.vaughn@fda.hhg.gov.